Amebic Dysentery, Anaerobic Infection, Infectious Enterocolitis
Conditions
Brief summary
Secondary Data Collection Study; safety and effectiveness of Anaemetro under Japanese medical practice
Interventions
None listed
Sponsors
Pfizer
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients who have not used metronidazole (injection) in the past, and have been given this drug for treatment of anaerobic infection, infectious enterocolitis, or amebic dysentery. Patients who have used metronidazole (oral agent and vaginal tablet) in the past are eligible, and should not be excluded from this study.
Exclusion criteria
* No
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reaction (ADR) | Maximum 8 weeks | An adverse drug reaction (ADR) was any untoward medical occurrence attributed to ANAEMETRO Intravenous infusion in a participant who received ANAEMETRO Intravenous infusion. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to ANAEMETRO Intravenous infusion was assessed by the physician. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Response Rate | Maximum 8 weeks | Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as effective, not effective, or indeterminate by the physician based on clinical symptoms. Clinical response rate, which was defined as the percentage of participants evaluated as effective over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. |
| Clinical Response Rates by Target Diseases | Maximum 8 weeks | Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as effective, not effective, or indeterminate by the physician based on clinical symptoms. Clinical response rate, which was defined as the percentage of participants evaluated as effective over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Participants assessed as effective by the following target diseases were counted to assess whether they contribute to the clinical response: anaerobic infection, infectious enterocolitis, amebic dysentery, and the infection with both infectious enterocolitis and amebic dysentery. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ANAEMETRO Intravenous Infusion (Metronidazole) Participants who received ANAEMETRO Intravenous infusion as indicated in the approved local product document were observed for a period of maximum 8 weeks. The dosage can be adjusted as per physician's discretion. | 107 |
| Total | 107 |
Baseline characteristics
| Characteristic | ANAEMETRO Intravenous Infusion (Metronidazole) | — |
|---|---|---|
| Age, Customized ≥15 and <65 years | 40 Participants | — |
| Age, Customized <15 years | 0 Participants | — |
| Age, Customized ≥65 years | 67 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex/Gender, Customized Female | 38 Participants | — |
| Sex/Gender, Customized Male | 69 Participants | — |
| Target Diseases Amebic dysentery | 7 Participants | — |
| Target Diseases Anaerobic infection | 74 Participants | — |
| Target Diseases Infectious enterocolitis | 23 Participants | — |
| Target Diseases Infectious enterocolitis + amebic dysentery | 3 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 3 / 107 |
| other Total, other adverse events | 2 / 107 |
| serious Total, serious adverse events | 11 / 107 |
Outcome results
Primary
Number of Participants With Adverse Drug Reaction (ADR)
An adverse drug reaction (ADR) was any untoward medical occurrence attributed to ANAEMETRO Intravenous infusion in a participant who received ANAEMETRO Intravenous infusion. A serious ADR was an ADR resulting in any of the following outcomes or deemed significant for any other reason: death; life-threatening experience (immediate risk of dying); initial or prolonged inpatient hospitalization; persistent or significant disability/incapacity; congenital anomaly. Relatedness to ANAEMETRO Intravenous infusion was assessed by the physician.
Time frame: Maximum 8 weeks
Population: The safety analysis set comprised of participants who satisfied the inclusion criteria and had received ANAEMETRO Intravenous infusion at least once.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ANAEMETRO Intravenous Infusion (Metronidazole) | Number of Participants With Adverse Drug Reaction (ADR) | ADR | 7 Participants |
| ANAEMETRO Intravenous Infusion (Metronidazole) | Number of Participants With Adverse Drug Reaction (ADR) | Serious ADR | 1 Participants |
Secondary
Clinical Response Rate
Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as effective, not effective, or indeterminate by the physician based on clinical symptoms. Clinical response rate, which was defined as the percentage of participants evaluated as effective over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI.
Time frame: Maximum 8 weeks
Population: The clinical efficacy analysis set comprised of participants from the safety analysis set, excluding those with no information of clinical response or infections other than target disease. Participants evaluated as indeterminate (n=12) were excluded from the calculation.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ANAEMETRO Intravenous Infusion (Metronidazole) | Clinical Response Rate | 95.8 Percentage of Participants |
Secondary
Clinical Response Rates by Target Diseases
Clinical response of ANAEMETRO Intravenous infusion was evaluated comprehensively at the completion of the observation period, being assessed as effective, not effective, or indeterminate by the physician based on clinical symptoms. Clinical response rate, which was defined as the percentage of participants evaluated as effective over the total number of assessable effectiveness analysis population, was presented along with the corresponding 2-sided 95% CI. Participants assessed as effective by the following target diseases were counted to assess whether they contribute to the clinical response: anaerobic infection, infectious enterocolitis, amebic dysentery, and the infection with both infectious enterocolitis and amebic dysentery.
Time frame: Maximum 8 weeks
Population: The clinical efficacy analysis set comprised of participants from the safety analysis set, excluding those with no information of clinical response or infections other than target disease. Participants evaluated as indeterminate (IND) were excluded from the calculation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ANAEMETRO Intravenous Infusion (Metronidazole) | Clinical Response Rates by Target Diseases | Infectious enterocolitis (n=21) excluding IND(n=2) | 100.0 Percentage of Participants |
| ANAEMETRO Intravenous Infusion (Metronidazole) | Clinical Response Rates by Target Diseases | Amebic dysentery (n=7) | 100.0 Percentage of Participants |
| ANAEMETRO Intravenous Infusion (Metronidazole) | Clinical Response Rates by Target Diseases | Infectious enterocolitis + amebic dysentery (n=3) | 100.0 Percentage of Participants |
| ANAEMETRO Intravenous Infusion (Metronidazole) | Clinical Response Rates by Target Diseases | Anaerobic infection (n=64)excluding IND(n=10) | 93.8 Percentage of Participants |